tigecycline

tigecycline,

a broad-spectrum antiinfective.

indications This drug is used to treat complicated skin and skin structure infections caused by Escherichia coli, Enterococcus faecalis (vancomycin-susceptible only), Staphylococcus aureus, Streptococcus agalactiae, S. anginosus group, S. pyogenes, Bacteroides fragilis and complicated intraabdominal infections caused by Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, K. pneumoniae, E. faecalis (vancomycin-susceptible only), S. aureus (methicillin-susceptible only), S. anginosus group, Bacteroides fragilis, B. thetaiotaomicron, B. uniformis, B. vulgatus, Clostridium perfringens, and Peptostreptococcus micros.

contraindications Pregnancy, lactation, and known hypersensitivity to this drug prohibit its use. Children under 18 years of age should not use this drug.

adverse effects Adverse effects of this drug include headache; dizziness; insomnia; hypertension; hypotension; phlebitis; anorexia; constipation; dyspepsia; pruritus; sweating; photosensitivity; increased aspartate aminotransferase, alanine aminotransferase, blood urea nitrogen, lactic acid, alkaline phosphatase, and amylase; hyperglycemia; hypokalemia; hypoproteinemia; bilirubinemia; back pain; fever; abnormal healing; abdominal pain; abscess; asthenia; infection; pain; peripheral edema; and local reactions. Life-threatening side effects include anemia, leukocytosis, and thrombocytopenia. Common side effects include nausea, vomiting, and diarrhea.

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tigecycline

Tygacil

Pharmacologic class: Glycylcycline antibiotic

Therapeutic class: Anti-infective

Pregnancy risk category D

Action

Inhibits protein translation in bacteria by binding to 30S ribosomal subunit and blocking entry of amino-acyl tRNA molecules into ribosomal A site, which in turn prevents incorporation of amino acid residues into elongating peptide chains

Availability

Powder for injection (lyophilized): 50 mg/5 ml in single-dose vial

⊘Indications and dosages

➣ Skin and skin-structure infections caused by susceptible strains of Escherichia coli, Enterococcus faecalis (vancomycin-susceptible isolates only), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus agalactiae, Streptococcus anginosus group, Streptococcus pyogenes, and Bacteroides fragilis; complicated intra-abdominal infections caused by Citrobacter freundii, E. coli, Enterobacter cloacae, E. faecalis (vancomycin-susceptible isolates only), Klebsiella oxytoca, Klebsiella pneumoniae, S. aureus (methicillin-susceptible isolates only), S. anginosus group, S. pyogenes, B. fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Clostridium perfringens, and Peptostreptococcus micros

Adults age 18 and older: 100 mg I.V. initially, followed by 50 mg I.V. every 12 hours for 5 to 14 days, depending on infection site and severity and patient's clinical and bacteriologic process

Dosage adjustment

• Severe hepatic impairment

Contraindications

• Hypersensitivity to drug or its components

Precautions

Use cautiously in:
• mild to moderate hepatic impairment, complicated intra-abdominal infections secondary to perforation
• pregnant and breastfeeding patients
• children younger than age 18.

Administration

• Reconstitute with 5.3 ml of normal saline solution injection or 5% dextrose injection to yield a concentration of 10 mg/ml (50 mg).
• Swirl vial gently until drug dissolves. Immediately withdraw 5 ml of reconstituted solution from vial and add to 100-ml I.V. bag for infusion. Maximum concentration in I.V. bag should be 1 mg/ml.
• Discard reconstituted solution that isn't yellow or orange.
• Administer through dedicated I.V. line or Y-site. If same I.V. line is used for sequential infusion of several drugs, flush before and after infusion, using either normal saline solution injection or 5% dextrose injection. Use infusion solution compatible with tigecycline and other drugs given through same line.
• Administer over 30 to 60 minutes.
• Don't give amphotericin B, chlorpromazine, methylprednisolone, or voriconazole simultaneously through same Y-site.

Route	Onset	Peak	Duration
I.V.	Unknown	Unknown	Unknown

Adverse reactions

CNS: headache, dizziness, insomnia, asthenia

CV: hypertension, hypotension, phlebitis

GI: nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, increased GI enzymes, pseudomembranous colitis

Hematologic: anemia, leukocytosis, thrombocytopenia

Musculoskeletal: back pain

Respiratory: increased cough, dyspnea

Skin: pruritus, rash, sweating, photosensitivity

Other: abscess, fever, infection, pain, peripheral edema, abnormal healing, superinfection, allergic reaction

Interactions

Drug-drug. Hormonal contraceptives: reduced contraceptive efficacy

Drug-diagnostic tests. Alanine aminotransferase, alkaline phosphatase, amylase, aspartate aminotransferase, bilirubin, blood glucose, blood urea nitrogen: increased

Blood protein, potassium, WBCs: decreased

Patient monitoring

• Monitor prothrombin time or other suitable anticoagulation tests if patient is receiving warfarin concomitantly.
• Closely monitor patients with severe hepatic impairment.

Patient teaching

• Instruct patient to report rash and other signs or symptoms of allergic reaction.
• Tell patient to complete full course of therapy, even if he feels better.
• Advise patient taking oral hormonal contraceptives to use alternative birth control method during therapy.
• Caution female with childbearing potential to avoid pregnancy because drug may harm fetus.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.